Riding the wave of medicine loss-of-exclusivity to gain improved returns

As a biopharmaceutical product approaches the end of its patent life, executives believe that the product’s demise is inevitable and will happen at great speed. They begin to worry about the rapid loss of revenue that will be brought about by the entry of generic alternatives into the market. They believe that there are only two outcomes possible for the product: die quickly or die slowly. This fatalistic outlook motivates the selection of a loss-of-exclusivity (LOE) strategy to achieve a slow demise rather than a quick one.

Starting with an optimistic outlook, particularly with a medicine that has generated multiple billions of dollars in revenue and changed many lives for the better, an aspirational LOE strategy can be developed to weather the storm of generic entry, as well as use the entry of generics into the market as an opportunity to generate more revenue and do more for patients. This article proposes a framework for devising an aspirational LOE strategy, the ingredients needed to create the strategy, and a case study of success.